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Sterile Electrosurgical pencils
EUDAMEDClass IIb (EU MDR)
Ref SP200-P10S/92649Model SP200-P10SRef SP200-B200SRef SP200-P10S/92648Ref ESRK4001LQ
Identity
- Trade Name
- Sterile Electrosurgical pencils EUDAMED
- Device Name
- sterile eletrosurguical pencil EUDAMEDelectrosurgical electrode EUDAMEDElectrosurgical Pencil EUDAMEDsterile electrosurgical pencil EUDAMED
- Model / Reference
- SP200-P10S EUDAMEDSP200-P10S/92649 EUDAMEDSP200-B200S EUDAMEDSP200-P10S/92648 EUDAMEDESRK4001LQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971703290115 EUDAMED16971703290221 EUDAMED16971703290566 EUDAMED16971703290016 EUDAMED
- Basic UDI-DI
- B-16971703290115 EUDAMEDB-16971703290221 EUDAMEDB-16971703290566 EUDAMEDB-16971703290016 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMEDK0201010301,K0201010901 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMEDEUDAMED
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Sterile Electrosurgical pencils by Dongguan QueenMed Equipment Mfg Co Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16971703290115 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dongguan QueenMed Equipment Mfg Co Ltd
- EUDAMED SRN
- CN-MF-000006969
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED ccfb283f-b02b-43d9-9890-a20ee38065b0 61 fields · synced Jul 27, 2026
- EUDAMED 9f375b67-8a68-4b29-9ac7-5841802f10d0 61 fields · synced May 17, 2026
- EUDAMED 31cc78f1-4131-41aa-8981-e0329ba2deb5 61 fields · synced May 18, 2026
- EUDAMED 9aabc314-8ae0-4b30-8628-0506f1215f01 61 fields · synced May 19, 2026